Home Immunization with Palivizumab-A Randomized Pilot Study Describing Safety Aspects and Parents' Preferences
Christina Ebersjö1,2, Eva Berggren Broström1, Inger Kull1,2
1Department of Clinical Science and Education, Södersjukhuset, Karolinska Institute, 171 77 Stockholm, Sweden.
Insights
Home immunization with palivizumab is a safe and feasible option for vulnerable infants, reducing hospital visits. Parents preferred home administration, prioritizing their infant
Area of Science:
- Pediatrics
- Immunology
- Public Health
Background:
- Respiratory syncytial virus (RSV) infections pose significant risks for premature and chronically ill infants, potentially leading to hospital readmissions and respiratory issues.
- Palivizumab, a monoclonal antibody, offers therapeutic protection against RSV through monthly injections during the RSV season.
- Current standard care involves multiple clinic-based injections, increasing hospital revisits and exposure risks for vulnerable infants.
Purpose of the Study:
- To evaluate the safety and parental preferences of home versus hospital administration of palivizumab in high-risk infants.
- To explore the feasibility of home-based immunization as an alternative to clinic-based standard care.
Main Methods:
- A randomized pilot trial involving 43 infants from 38 families was conducted over one RSV season.
- Safety was assessed by monitoring immediate adverse events (AEs) by nurses and late-onset AEs reported by parents.
- Parental perceptions and preferences were gathered through questionnaires and analyzed using content analysis.
Main Results:
- No immediate adverse events were observed during home or hospital immunization.
- Three late-onset AEs were reported in two infants within the home immunization group.
- Content analysis revealed parental themes centered on infant protection, family well-being, and minimizing infant suffering.
Conclusions:
- Home immunization with palivizumab is a feasible and safe option for vulnerable infants when safety considerations are addressed.
- Parental involvement in choosing the immunization setting, particularly after neonatal intensive care, is crucial for optimizing care and well-being.
Abstract:
Among prematurely born infants and newborns with chronic conditions, a respiratory syncytial virus (RSV) infection may cause (re-)admission and later respiratory complications. Therapeutic protection is possible with monthly injections of a specific monoclonal antibody, palivizumab, during RSV season. Standard care is giving up to five injections in clinic-based settings. Immunization at home could be an alternative to standard care for vulnerable infants to reduce the number of revisits and associated risk of RSV infection. The aim of this randomized pilot trial was to evaluate safety aspects and explore parents' preferences of home versus hospital immunization with palivizumab during one RSV season. Immediate adverse events (AEs) were observed and registered by a pediatric specialist nurse. Late-onset AEs were reported by parents. Parents' perceptions were collected through a questionnaire and analyzed using content analysis. The study population consisted of 43 infants in 38 families. No immediate AEs occurred. Three late-onset AEs were reported in two infants in the intervention group. Three categories emerged in the content analysis: (1) protect and watch over the infant, (2) optimal health and well-being for the whole family, and (3) avoid suffering for the infant. The study results show that home immunization with palivizumab is feasible if safety aspects are considered and that parental involvement in the choice of place for immunization after a neonatal intensive care experience can be important.
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